ASTM F1925-99e1
(Specification)Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants
Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants
SCOPE
1.1 This specification covers virgin poly(L-lactic acid) resin (or abbreviated as PLLA resin) intended for use in surgical implants. This specification does not cover stereoisomeric composition based on various D, L, DL copolymer ratios.
1.2 This specification addresses material characteristics of virgin poly(L-lactic acid) resin and does not apply to packaged and sterilized finished implants fabricated from this material.
1.3 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, etc.) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using those test methods which are appropriate to assure safety and efficacy.
1.4 The values stated in SI units are to be regarded as the standard.
1.5 The following precautionary statement pertains only to the test method portion, Section 6, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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e1
Designation: F 1925 – 99
Standard Specification for
Virgin Poly(L-Lactic Acid) Resin for Surgical Implants
This standard is issued under the fixed designation F1925; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
e NOTE—Figure 2 was editorially added in July 2001 because it had been inadvertently left out of the previous edition.
1. Scope Liquid Size-Exclusion Chromatography (Gel Permeation
Chromatography - GPC) Using Universal Calibration
1.1 Thisspecificationcoversvirginpoly(L-lacticacid)resin
D3892 Practice for Packaging of Plastics
(or abbreviated as PLLA resin) intended for use in surgical
F748 Practice for Selecting Generic Biological Test Meth-
implants. This specification does not cover stereoisomeric
ods for Materials and Devices
compositions based on various D, L, or DL copolymer ratios.
2.2 ISO Standard:
1.2 This specification addresses material characteristics of
ISO/DIS 10993-9, Biological Evaluation of Medical De-
virginpoly(L-lacticacid)resinanddoesnotapplytopackaged
vices, Part 9 Degradation of Materials Related to Biologi-
and sterilized finished implants fabricated from this material.
cal Testing, Annex A
1.3 As with any material, some characteristics may be
altered by processing techniques (such as molding, extrusion,
3. Terminology
machining, assembly, sterilization, and so forth) required for
3.1 Definitions of Terms Specific to This Standard:
the production of a specific part or device. Therefore, proper-
3.1.1 generic property—that property which is determined
ties of fabricated forms of this resin should be evaluated using
solely by the chemical composition and structure of the virgin
those test methods which are appropriate to assure safety and
polymer
efficacy.
3.1.2 virgin polymer—the form of poly(L-lactic acid) as
1.4 The values stated in SI units are to be regarded as the
obtained from the manufacturer and before fabrication into a
standard.
medical device.
1.5 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
4. Virgin Poly(L-Lactic Acid) Resin Requirements
responsibility of the user of this standard to establish appro-
4.1 Generic Properties:
priate safety and health practices and determine the applica-
4.1.1 The virgin polymer shall be a homopolymer of
bility of regulatory limitations prior to use.
L-lactide with a density between 1.20 and 1.28 g/cm (see 6.5
2. Referenced Documents for evaluation method).
4.1.2 The molecular mass of the virgin polymer shall be
2.1 ASTM Standards:
indicated by relative solution viscosity in accordance with 6.2.
D1505 Test Method for Density of Plastics by the Density-
2 In addition to solution viscosity (but not in place of), weight
Gradient Technique
3 average molecular mass and molecular mass distributions may
D1898 Practice for Sampling of Plastics
3 be determined by gel permeation chromatography (GPC)
D2857 Practice for Dilute Solution Viscosity of Polymers
according to Test Methods D3536 or D3593.
D3536 Test Method for Molecular Weight Averages and
4.1.3 The virgin polymer shall be identified as a polylactide
Molecular Weight Distribution by Liquid Exclusion Chro-
4 by infrared or H-NMR spectroscopy.
matography (Gel Permeation Chromatography - GPC)
4.1.3.1 The virgin polymer shall yield an infrared spectrum
D3593 Test Method for Molecular Weight Averages and
whichexhibitsmajorabsorptionbandsonlyatthewavelengths
Molecular Weight Distribution of Certain Polymers by
that appear in a suitable reference spectrum.Atypical infrared
transmission spectrum is shown in Fig. 1.
4.1.3.2 Additional absorption bands may be indicative of
This specification is under the jurisdiction of ASTM Committee F04 on
known,orunknown,impuritiesincludingresidualsolventsand
Medical Surgical Materials and Devicesand is the direct responsibility of Subcom-
catalysts (refer to residual solvent limits specified in Table 1).
mittee F04.11 on Polymeric Materials.
Current edition approved Nov. 10, 1999. Published January 2000. Originally
published as F1925–98. Last previous edition F1925–98.
2 5
Annual Book of ASTM Standards, Vol 08.01. Annual Book of ASTM Standards, Vol 13.01.
3 6
Annual Book of ASTM Standards, Vol 08.02. Available from American National Standards Institute, 25 W. 43rd St., 4th
Annual Book of ASTM Standards, Vol 08.03. Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 1925
FIG. 1 Poly(L-Lactic Acid) Resin Infrared Spectrum
TABLE 1 Physical/Chemical Property Requirements of Virgin
Poly(L-Lactic Acid) Resins
Heavy
Residual
Residual Residual Tin Metals, Sulfated
Analyte Solvent(s),
Water, % (Sn), ppm (as Lead), Ash, %
(Total, %)
ppm
Requirement #0.01 #0.5 #200 #300 #0.1
4.1.3.3 Aninfraredspectrumcannotdistinguishbetweenthe
different available stereoisomeric polylactic acids. It is used
here only as a means of identifying the material as a polylac-
tide.
4.1.3.4 The virgin polymer shall yield a H-NMR spectrum
which exhibits major absorption bands only at the frequencies
thatappearinasuitablereferencespectrum.Atypical H-NMR
spectrum is shown in Fig. 2.
4.1.3.5 Additional absorption bands may be indicative of
known,orunknown,impuritiesincludingresidualsolventsand
monomers, and catalysts (refer to residual solvent, monomer,
and tin (catalyst) limits specified in Table 1) and 4.1.5.
4.1.3.6 A H-NMR spectrum cannot distinguish between
thedifferentavailablestereoisomericpolylacticacids.Itisused
FIG. 2 Poly(L-Lactic Acid) Resin H-NMR Spectrum
here only as a means of identifying the material as a polylac-
tide.
4.1.4 The virgin polymer shall have a specific optical than2dL/gandintendedforinjectionmoldingorload-bearing
rotation between −155 and −160° when measured as specified applications shall not have a residual mono
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